The present invention relates to a non-alcoholic, effervescent compound in wet or dry form for use as a delivery system for orally ingestible active ingredients, such as mouthwashes, cough and cold remedies, antipyretics, antacids, sleep aids and prescription and non-prescription drugs.
All individuals have varying minimum levels of bacteria found in their bodies. The sources of the different types of bacteria are diverse and, for example, may range from eating, to atmospheric and environmental conditions, to a simple contact with unspecified articles or one's hands and fingers. While the general types of bacteria are not ever likely to be completely eliminated, effective control of harmful bacterial growth is desired for good hygiene.
The principal growth stimuli for harmful oral bacteria are residual food and food sugars coupled with the natural moisture and temperature conditions of the mouth. Under such conditions, these stimuli provide for explosive growth of harmful bacteria. These oral bacteria secrete acidic residues which further exacerbate and increase instances of poor health, dental caries and periodontal disease.
Decaying food particles which become trapped between teeth or between teeth and gum areas also are inconvenient or difficult to remove and contribute to higher levels of acidity and poor health, dental caries and periodontal disease.
Compounds designed to clean the oral cavity and provide fresh breath are known. Generically, such compounds fall into two groupings: dentifrices and mouthwashes. Other compounds, generically described as breath mints or breath fresheners which may be delivered in gums, liquids, sprays or small tablet shapes, are not considered oral cavity cleaners.
Many orally ingestible preparations, such as mouthwashes, cold remedies, antipyretics, antacids, sleep aids and prescription and non-prescription drugs are supplied to users in solutions, some of which contain varying amounts of alcohol or solvents. Alcohol in such solutions has long been believed necessary as a solvent to dissolve the active ingredients and flavoring oils in such solutions. For example, alcohol is used as a solvent in mouthwashes, cough medicines and cold preparations in which decongestants, antihistamines, flavoring additives, and cough suppressants can be dissolved. Concentrations of flavoring oils in solution with alcohol often serve to mask the unpalatable taste of the active ingredients.
While the use of alcohol as a solvent enables the inclusion of various active ingredients and flavoring oils into a liquid, the inclusion of alcohol usually is not necessary for the effectiveness of the compound and can have many detrimental side effects upon the user of such compounds. Beyond presenting potential medical and health problems, its inclusion in orally ingested products also presents potential social implications for some users.
The medical implications of using alcohol in an orally ingested preparation are validated, for example, by explicit warning labels on mouthwashes and cough and cold preparations concerning the drowsiness which may result from ingesting the alcohol within the preparation, and recommendations to avoid operating heavy machinery and automobiles after ingesting the preparation. Also, individuals who can not afford to purchase liquor sometimes drink less expensive mouthwashes and cold and cough remedies to obtain the alcohol contained therein, risking the detrimental effects of ingesting a stimulant they do not need, as well as increasing their risk of overdosing on the stimulant.
Ingesting alcohol can have a range of from little impact up to and including death, depending upon the individual. If the individual is a toddler or a person over age 60, there is a distinct difference in metabolic absorption capabilities as compared to persons between these age categories. For example, many widely-sold mouthwashes, cough remedies and cold preparations carry label warnings against use by individuals age six and under. It is generally known that as a person ages past 60 his or her general ability to metabolize alcohol gradually diminishes until, by age 80, it reaches that of an approximately six year old child's metabolic absorption.
Additionally, alcohol and its abuses is a recognized major social problem. Abuse of alcohol in all its forms is considered an illness, and in some schools of thought, is believed to be passed genetically. Contact with nonbeverage alcohol can trigger setbacks in recovering alcoholics.
Accidental poisonings from ingesting alcohol-based products such as mouthwash and cold remedies have occurred. Further, accidental ingestion of alcohol-based products by diabetics may cause a dangerous insulin deficiency, as insulin is utilized by the body in digesting alcohol.
Economically, alcohol is the preferred solvent for many orally ingested additives. Solutions which contain alcohol taste better than those which do not, because alcohol acts as a solvent to dissolve flavoring oils. Further, together with masking the unpleasant tastes of active ingredients, relatively high concentrations of flavoring oils, such as peppermint or spearmint oil, are known to have an antimicrobial affect in a user's mouth and on teeth and gums, possibly descreasing the instance of tooth decay. An effective, orally ingestible delivery system for a broad range of active ingredients, prescriptive or non prescriptive, which contains high concentrations of flavoring oils and no alcohol, has been thought desirable but heretofore has not been available.
A large amount of all orally ingestible compounds, including mouthwashes, cold remedies and cough formulas, are packaged as liquids whose principal volume and weight comprises water. They are packaged in clear plastic containers without protective outer packaging, and are subject to product tampering, such as by "hair hypodermic" needles which can inject contaminants or poisons without being noticed by the consumer. Transportation of orally ingestible products in a dry form, and in single dosage, moistureproof packets enclosed in a general external consumer package or box, makes it more difficult to contaminate the product. Further, such compounds are much less expensive to transport in dry form than in liquid form. In many cases, the effectiveness of active ingredients is prolonged in a dry, rather than liquid, state.
Other orally ingestible compounds, particularly pain relievers and prescription drugs, are supplied in large tablet or capsule form, which some users find difficult to swallow, and which are difficult to administer to small children. These compounds often also have a known bitterness and are often difficult to administer to children, seniors, and other healthcare patients. The vast majority of pain relievers are available only in tablet form. It long has been desired to have a good tasting, water-soluble delivery of pain relievers to correct current difficulties and enhance indivicual compliance with recommended dosages.
Some vitamins also have a known bitterness and are difficult to administer to children as well as adults because of their traditional pill form of delivery. Vitamins which have been successful for children have been artificially colored or sweetened to mask the bitterness or may have been made chewable like candy to secure children's compliance with daily recommended dosage requirements. There are several liquid over-the-counter vitamin products which use comparable amounts of alcohol as a solvent as do many mouthwashes. The alcohol content ranges are from 5% to 20%. A water-soluble delivery system for vitamins thus is desirable.
Dry and tablet form orally ingestible compounds are known. For examples, U.S. Pat. Nos. 3,772,431 and 3,888,976 to Milkvy et al. disclose a dry tablet compound which, upon dissolution, provides a solution with desensitizing action to the teeth, effervescent cleaning action and gingival toning. Both patents disclose a basic mouthwash formulation, but do not address specific formulations or a delivery system for cold remedies, pain relievers, vitamins or prescription drugs. Milkvy et al also do not disclose the use of spray-dried flavoring oils.
Mouthwash tablets are disclosed in U.S. Pat. Nos. 3,577,490, 3,629,468, and 3,518,343. Each of the patents concerns a method for the manufacture of effervescent tablets which may be used for cleaning solid surfaces, including the teeth and gum areas of the oral cavity. For example, U.S. Pat. Nos. 3,518,343 and 3,577,490 to Welsh et al. address unsuccessful prior art effervescent tablets and the need for an effective tableting lubricant and water-soluble anti-microbial agent to improve manufacturing processes for water-soluble tablets containing antimicrobial agents. Welsh et al. do not address a delivery system for cold remedies, cough suppressants, vitamins, pain relievers and prescription drugs, but rather, disclose means to manufacture mouthwash tablets. U.S. Pat. No. 3,629,468 to Anderson also addresses inadequacies of prior methods of producing effervescent tablets and discloses a method of manufacture which eliminates heating and drying steps, increases storage life of the resulting product, and eliminates the need for inclusion, in the compounds, of inert fillers or buffers. In addition, Welsh et al and Anderson use a very small concentration of flavorings.
Cold preparations in effervescing tablet form also are known. However, because these tablets do not contain alcohol or another solvent, they do not contain high concentrations of flavoring oils and as a result have a weak or bitter taste.
It also is known to use flavorings in the form of spray-dried oils. See, for example, Cherukuri U.S. Pat. Nos. 4,753,805 and 4,803,082. However, those patents do not disclose the use of large concentrations of spray-dried flavorings as part of a delivery system for active ingredients. Other such patents are disclosed in the file history of applicants' above-mentioned patent application.